Respironics Sealeasy II
FDA 510(k) K890795 · Respironics, Inc.
510(k) numberK890795
Submission
- Device name
- Respironics Sealeasy II
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- February 17, 1989
- Decision date
- April 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSJ – Mask, Gas, Anesthetic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5550
- Specialty
- Anesthesiology
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|---|---|---|---|
| K163277 | SuperNO2VA DeviceBSJ · Traditional | Revolutionary Medical Devices, Inc. | 10/13/2017SE |
| K953107 | Anesthesia/Respiratory Face MaskBSJ · Traditional | Medical Marketing Concepts | 08/15/1995SE |
| K953295 | Anesthesia Face MaskBSJ · Traditional | Mallinckrodt Medical | 08/11/1995SE |
| K952689 | Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional | Owens-Brigam Medical Co. | 07/11/1995SE |
| K951043 | Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional | Promedic, Inc. | 06/07/1995SE |
| K950771 | Disposable Adhesive Face MaskBSJ · Traditional | Advanced Warming Systems, Inc. | 03/10/1995SE |
| K945894 | Mask, Gas, AnestheticBSJ · Traditional | Hans Rudolph, Inc. | 01/27/1995SE |
| K945440 | Disposable, Anesthesia/Respiratory Face MaskBSJ · Traditional | Fvtnks | 11/08/1994SE |
| K944157 | Disposable, Preformed Face MaskBSJ · Traditional | Meridian Medical Systems, Inc. | 10/03/1994SE |
| K932147 | Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional | Hans Rudolph, Inc. | 08/20/1993SE |
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| 510(k) | Device | Decision |
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| K231313 | Therapy Mask 3100 NC/SPBZD · Special | 07/28/2023SE |
| K210844 | DreamWear Silicone Pillows MaskBZD · Traditional | 08/24/2021SE |
| K210386 | Magneto Nasal MaskBZD · Traditional | 07/12/2021SE |
| K202142 | Sleepware G3OLZ · Traditional | 10/29/2020SE |
| K201439 | Ventilator, Non-continuous (Respirator)BZD · Traditional | 09/25/2020SE |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced SystemBZD · Traditional | 07/10/2020SE |
| K183625 | SomnaPatchMNR · Traditional | 10/18/2019SE |
| K183226 | Care Orchestrator EssenceBZD · Traditional | 10/18/2019SE |
| K181170 | Trilogy Evo UniversalCBK · Traditional | 07/18/2019SE |
Questions and answers
When was Respironics Sealeasy II cleared by the FDA?
Respironics Sealeasy II (K890795) received a 510(k) decision of Substantially Equivalent on April 20, 1989, 62 days after the submission was received.
What is the product code of K890795?
The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.